Status:
COMPLETED
Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)
Lead Sponsor:
Shenyang Sunshine Pharmaceutical Co., LTD.
Conditions:
ITP
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a review of the efficacy and safety of different recombinant human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP).
Detailed Description
Evaluating the efficacy and safety of different human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP) This trial was designed as a multicenter, ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old, male or female
- For patients who have been diagnosed with ITP, the diagnostic criteria are consistent with the Chinese Expert Consensus on Diagnosis and Treatment of Primary Immune Thrombocytopenia (2016 Edition)
- Recurrence after previous treatment with glucocorticoids is ineffective or effective
- No contraindications to rhTPO (Terbyus) application, and willing to accept rhTPO treatment
- Platelet count before enrollment ≤ 30 × 109 / L, or \> 30 × 109 / L but with active bleeding
- Volunteer to participate in the study and sign the informed consent form
Exclusion
- pregnant or lactating
- Those with a history of thrombosis
- severe cardiopulmonary liver and kidney dysfunction: creatinine level ≥ 176.8μmol / l (2mg / dl), transaminase, bilirubin levels higher than the upper limit of the normal value of 3 times
- Those who have used rhTPO in the past 2 weeks, or who have undergone splenectomy within 2 months, or who have been treated with danazol for less than 1 month, or have recently applied the following ITP treatments but have not yet reached the efficacy judgment time. : C-ball (7 days), vincristine or vinblastine amide or rhIL-11 (2 weeks), Eltrombopag (1 month), or rituximab (2 months)
- In the case of previous treatment of rhTPO: rhTPO 300U/kg/d, 14 days of treatment is invalid;
- Severe or uncontrollable infections
- have a history of mental illness
- The investigator believes that the patient is not eligible to participate in any other circumstances of the trial.
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT04089267
Start Date
December 1 2016
End Date
August 1 2019
Last Update
September 13 2019
Active Locations (21)
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1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
2
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China, 361004
3
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260
4
Guangdong Second People's Hospital
Guangzhou, Guangdong, China, 510317